FDA UDI
In Commercial Distribution
🇺🇸 United States
Fixone Biocomposite Interference Screw
DI: 08800039101301
·
Model: IAB-10025a
·
AJU PHARM. CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fixone Biocomposite Interference Screw
- Primary DI
- 08800039101301
- Version / Model
- IAB-10025a
- Company Name
- AJU PHARM. CO., LTD.
- Labeler DUNS
- 963422810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-06
- Public Version
- 1
- Public Version Date
- 2025-01-14
- Public Version Status
- New
- Public Device Record Key
- c4b34b8f-1d82-4017-bb17-9768c276c275
Device Description
The Fixone Biocomposite Interference Screws are intended to be used for fixation of bone-tendon-bone or softtissue grafts during anterior or posterior cruciate ligament reconstruction surgery.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45039 | Bioabsorbable orthopaedic bone screw | A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800039101301 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193497 | 000 |